Kornimate/medical-research-clean huggingface dataset:
functional lung avoidance for individualized radiotherapy (flair): a randomized, double-blind clinical trial

Conditions: Non-small Cell Lung Cancer

Summary: concurrent chemoradiotherapy is the standard treatment for locally advanced, unresectable non-small cell lung cancer, but carries a risk of radiation pneumonitis of approximately 30%, and is associated with a decline in pulmonary quality of life. standard radiation planning aims to optimize dose to the anatomic lung volume, without consideration of the differences in regional lung function. functional lung avoidance radiotherapy aims to reduce radiotherapy dose to regions of functioning lung, instead depositing dose in areas of lung that are not well-ventilated. functional lung regions are determined using noble-gas mri and co-registered to the radiotherapy planning ct scans. functional lung avoidance radiotherapy has been demonstrated to be feasible, and this trial aims to compare outcomes between standard radiotherapy (with concurrent chemotherapy) vs. functional lung avoidance radiotherapy (with concurrent chemotherapy).

all consenting patients will undergo hyperpolarized noble gas mri using 3-he for definition of functional lung volumes. two radiotherapy treatment plans will be generated prior to randomization: one standard plan using anatomical lung avoidance, and one functional lung avoidance plan. after approval of both plans, patients will be randomized, and both patients and physicians will be blinded to treatment allocation.

Eligibility criteria:
inclusion criteria: * age 18 or older * willing to provide informed consent * ecog performance status 0-2 * histologically confirmed non-small cell lung carcinoma * locally advanced stage iiia or iiib lung carcinoma according to ajcc 7th edition * history of at least 10-pack-years of smoking * not undergoing surgical resection * assessment by medical oncologist and radiation oncologist, with adequate bone marrow, hepatic and renal function for administration of platinum-based chemotherapy exclusion criteria: * contraindications to mri * serious medical comorbidities (such as unstable angina, sepsis) or other contraindications to radiotherapy or chemotherapy * prior history of lung cancer within 5 years * prior thoracic radiation at any time * metastatic disease. patients who present with oligometastatic disease where all metastases have been ablated (with surgery or radiotherapy) are candidates if they are receiving chemoradiotherapy to the thoracic disease with curative intent. * inability to attend full course of radiotherapy or follow-up visits * pregnant or lactating women

Keywords: non-small cell lung cancer, radiotherapy, chemotherapy, pneumonitis, functional lung avoidance
safety and efficacy of mobic® ampoules in the initiation of treatment of painful exacerbations of osteoarthritis, rheumatoid arthritis and other similar painful inflammatory conditions

Conditions: Arthritis, Rheumatoid

Summary: study to determine the safety and efficacy of mobic® ampoules in the initiation of treatment of painful exacerbations of osteoarthritis, rheumatoid arthritis and other similar painful inflammatory conditions.


Eligibility criteria:
inclusion criteria: * painful acute exacerbations of inflammatory rheumatism (rheumatoid arthritis and ankylosing spondylitis), painful acute exacerbations of osteoarthritis and other similar conditions requiring acute treatment with an anti-inflammatory drug exclusion criteria: * none
combining cutting and drug-eluting balloon for resistant arteriovenous fistula stenosis (concerto)

Conditions: Arteriovenous Fistula Stenosis

Summary: to evaluate the preliminary efficacy of combination of cutting and drug-coated balloon for the treatment of resistant avf stenosis.

this is a single arm pilot study recruiting 19 participants with resistant avf stenosis (defined as having \> 30% residual stenosis after optimal balloon angioplasty) to receive cutting and drug-coated balloon. the outcome measure is target lesion primary patency at 6 months. outcome will be clinically driven.

Eligibility criteria:
inclusion criteria: 1. failing mature upper limb avf 2. resistant stenosis (\>30% residual stenosis) after optimal conventional balloon angioplasty (appropriately sized balloon, inflated up to rated burst pressure, at least twice for at least a minute per inflation) 3. patient is \>= 21 years of age 4. ability to provide informed consent exclusion criteria: 1. thrombosed avf 2. target lesion has a sharp angle (\> 45 degrees) 3. lesions requiring cutting balloon size \> 7 mm 4. coagulopathy or thrombocytopaenia that cannot be adequately managed for the procedure 5. contraindication to dual antiplatelet therapy 6. severe allergy to contrast media that cannot be adequately managed for the procedure 7. breast-feeding and/or pregnant females 8. male patients who are planning to father children during the trial period 9. unable to comply with follow up protocol (for instance, limited life expectancy)

Keywords: arteriovenous fistula drug-coated balloon cutting balloon stenosis
factors predicting persistence of oncogenic hpv and cervical dysplasia in hiv infected kenyan women

Conditions: HIV/AIDS; Cervical Dysplasia; HIV Infections

Summary: this study will utilize a longitudinal study design to better understand the natural history of oncogenic human papillomavirus (hpv) infections in human immunodeficiency virus (hiv)-infected and hiv-uninfected kenyan women, including the potentially modifiable (and non-modifiable) factors that are associated with progression of oncogenic hpv infection to clinical disease, including cervical cancer.


Eligibility criteria:
inclusion criteria: 1. kenyan women who present for a cervical cancer screening at ampath-cervical cancer screening clinics at mtrh or webuye and living in or within 30 km of the respective clinic at the time of informed consent 2. between the ages of 18 -45 years old at the time of informed consent 3. ability to provide written informed consent and hipaa authorization 4. must have a normal via 5. must be willing and able to come to the clinic for visits and return for a 4 year follow-up visit exclusion criteria: 1. history of an abnormal via or pap smear 2. diagnosis of cin or cervical cancer 3. signs or symptoms of a sexually transmitted infection (sti) 4. women who are currently pregnant 5. inability to understand and provide written informed consent due to a mental or physical disability, or a medical illness that has rendered the patient unable to understand consent or attend quarterly visits

Keywords: hpv hiv
a dose ranging study of ain457 in patients with moderate to severe chronic plaque-type psoriasis

Conditions: Chronic Plaque-type Psoriasis

Summary: the purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, ain457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).


Eligibility criteria:
inclusion criteria: chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization at randomization, moderate to severe psoriasis as defined by: * pasi score of 12 or greater and, * iga score of 3 or greater and, * body surface area (bsa) affected by plaque-type psoriasis of 10% or greater at screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by topical treatment. exclusion criteria: * forms of psoriasis other than chronic plaque-type * drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at randomization * previous exposure to ain457 * ongoing use of prohibited psoriasis treatments / medications and other prohibited medication at randomization. washout periods detailed in the protocol have to be adhered to * known immunosuppression (e.g., aids) at screening and / or randomization * history or evidence of active tuberculosis at screening * active systemic infections (other than common cold) * history or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years. * any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study * any clinically significant abnormal laboratory tests at randomization, that in the judgment of the investigator prevents the patient from participating in the study * inability or unwillingness to undergo repeated venipuntures * history or evidence of drug or alcohol abuse * pregnant or nursing (lactating) women other protocol-defined inclusion/exclusion criteria may apply

Keywords: moderate to severe chronic plaque-type psoriasis ain457 dermatology
a comparison of two contact lenses

Conditions: Refractive Error; Myopia

Summary: this study seeks to evaluate the clinical and subjective performance of two established soft contact lenses.


Eligibility criteria:
inclusion criteria: 1. they are of legal age (18 years) and capacity to volunteer. 2. they understand their rights as a research subject and are willing to sign a statement of informed consent. 3. they are willing and able to follow the protocol. 4. they would be expected to attain at least 6/9 (20/30) in each eye with the study lenses. 5. they are able to wear contact lenses with a back vertex power of -1.00 to -6.00ds. 6. they have a maximum of 1.00d of refractive astigmatism (i.e. ≤ 1.00 dc). 7. they have successfully worn contact lenses within six months of starting the study. exclusion criteria: 1. they have an ocular disorder which would normally contra-indicate contact lens wear. 2. they have a systemic disorder which would normally contra-indicate contact lens wear. 3. they are using any topical medication such as eye drops or ointment. 4. they are aphakic. 5. they have had corneal refractive surgery. 6. they have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus. 7. they are pregnant or lactating. 8. they have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear. 9. they have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. hiv). 10. they have diabetes. 11. they have taken part in any other clinical trial or research, within two weeks prior to starting this study.
vtx958 for the treatment of moderately to severely active crohn's disease

Conditions: Crohn Disease

Summary: this is a multicenter, randomized, double-blind placebo-controlled, parallel group study to evaluate the efficacy and safety of vtx958 in participants with moderately to severely active crohn's disease.

this is a multicenter, randomized, double-blind placebo-controlled, parallel group study to evaluate the efficacy and safety of vtx958 in participants with moderately to severely active crohn's disease. approximately 132 eligible patients will be randomized, and randomization will be stratified by prior use of biologics for the treatment of cd (yes/no). the study consists of a 30-day screening period, a 12-week double-blind induction treatment period, a 40-week double-blind maintenance treatment period, an open-label extension (ole) of up to 144 weeks, and a 30-day safety follow-up period. the maximum duration of treatment will be 36 months, including the induction, maintenance, and ole periods. for all participants, a follow-up visit will be performed at 30 days after the last dose of study drug. objectives primary objectives \* evaluate the efficacy of vtx958 in achieving reduction in crohn's disease activity index (cdai) score and endoscopic response at the end of the induction period secondary objectives * evaluate the efficacy of vtx958 in inducing clinical and symptomatic response and remission at the end of the induction period * evaluate the efficacy of vtx958 in inducing endoscopic response and clinical remission at the end of the induction period

Eligibility criteria:
inclusion criteria: 1. men or women, 18 to 75 years of age, inclusive, at the time of consent 2. capable of giving signed informed consent 3. documented diagnosis of cd ≥ 3 months prior to day 1. the diagnosis of cd must be confirmed by clinical, endoscopic, and histologic evidence. 4. moderately to severely active cd exclusion criteria: 1. current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, or infectious colitis 2. presence of a stoma or ileoanal pouch 3. presence of currently known complications of cd such as symptomatic bowel stricture(s) and \>2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, left and sigmoid colon, and rectum, fulminant colitis, toxic megacolon or any other manifestation that may require surgery or hospitalization 4. known diagnosis of short gut or bowel syndrome 5. previous exposure to vtx958 or any other tyk2 inhibitor (eg, deucravacitinib) in any study

Keywords: vtx958 harmony crohn's disease tyk2
the efficacy and safety of the dried biological amnion graft in patients with intrauterine adhesions

Conditions: Intrauterine Adhesions

Summary: to estimate the efficacy and safety of dried biological amnion graft after hysteroscopic lysis of intrauterine adhesions.

allocation: randomized endpoint classification: safety/efficacy study intervention model: parallel assignment masking: single blind (subject) primary purpose: prevention

Eligibility criteria:
inclusion criteria: * age 20-40 years； * previously diagnostic hysteroscopy confirmed adhesion score \>5， according to the american fertility society （afs）classification of iua； * complains of menstruation disorder and reproductive dysfunction； * informed consent. exclusion criteria: * premature menopause, * presence of other intrauterine lesions (e.g. polyps, myoma, septa), and * presence of severe intercurrent illness (e.g. systemic disease, coagulative disorders, severe kidney and liver diseases), * adhesions limited to the lower uterine cavity or the cervical canal.

Keywords: amnion graft new biological barrier system
investigation of treating chronic fatigue syndrome after covid with pharmacotherapy (pregabalin) or complex rehabilitation

Conditions: Chronic Fatigue Syndrome; COVID-19, Long Haul

Summary: this is a single-center, prospective, randomized, double-blind (pharmacotherapy), placebo-controlled, and comprehensive rehabilitation phase ii clinical trial to determine the usefulness of pregabalin in a new indication (post-covid chronic fatigue syndrome). patients will be randomized in a 1:1:1:1 ratio to pregabalin (75-300 mg daily in two divided doses), comprehensive rehabilitation with a placebo drug, comprehensive rehabilitation with pregabalin (75-300 mg in two divided doses), or placebo (two divided doses) for 6 months (177-187 days). there will be 4 outpatient visits to the research center and 12 telephone consultations. the procedures and assessments performed as part of the study are listed in the study schedule. it is planned to include 132 patients in the study, which, assuming a 10% level of non-completion of the program, will result in the examination of 120 patients (30 in each arm). patients will be recruited during an outpatient medical consultation with a general practitioner or neurologist, psychiatrist, psychologist or other specialists, as well as with the use of information materials in the form of leaflets and advertisements on the internet.


Eligibility criteria:
inclusion criteria: 1. the patient correctly gave written informed consent to participate in the study; 2. men or women between the ages of 18 and 65 inclusive at the time of signing the informed consent; 3. patient after a minimum of 6 months from the documented detection of sars-cov-2 infection (document confirming the history of the disease, including a positive result of the pcr or antigen test, certificate of convalescence; medical documentation confirming the infection; the condition is also considered fulfilled in the case of documented infection asymptomatic); 4. during the screening, the patient meets the criteria for the diagnosis of chronic fatigue syndrome (cfs) according to the national academy of medicine (2015); 5. women: a) incapable of having children (post-menopausal or child-bearing, subjected to permanent sterilization); (b) of childbearing potential with a negative pregnancy test result at screening and using a highly effective method of contraception throughout the imp use and for 7 days after the last imp use. 6. the patient agrees to participate in all activities provided for in the study. 7. the patient is able to understand the information presented and give informed consent to participate in the study prior to screening. exclusion criteria: 1. vital functions disorders; 2. documented hypersensitivity to pregabalin or any of the excipients of the formulation (i.e., lactose); 3. moderate or severe depression during treatment or present during psychiatric evaluation at baseline; 4. concurrent treatment with opioids or other antiepileptic drugs (including tramadol, buprenorphine, morphine, oxycodone, gabapentin, duloxetine); 5. pregnant or breastfeeding women.

Keywords: chronic fatigue syndrome associated with post-covid syndrome
multispectral digital colposcope with probe for detection of cervical intraepithelial neoplasia

Conditions: Carcinoma in Situ of Uterine Cervix; Cervical Intraepithelial Neoplasias; High Grade Cervical Intraepithelial Neoplasia

Summary: although cervical cancer is a preventable cancer, every year more than one-quarter of a million women die worldwide from this disease. internationally and nationally, cervical cancer is a disease that affects predominantly women who are poor and who live in resource poor settings. with the device the investigators are developing, known as the multispectral digital colposcope with probe, our goal is to make detection of precancerous cervical lesions easier for the patient and for her provider. for the patient, our goal is to reduce the number of clinical visits needed to obtain a diagnosis and treatment and consequently to reduce the resulting fear and anxiety which usually accompanies an abnormal pap smear. for the provider and the health care system, our goal is to obtain a more accurate diagnosis than the currently available diagnostic methods.

the multispectral digital colposcope (mdc) is a specialized lightsource and imaging device mounted on a custom-made colposcope that acquires a sequence of fluorescence images. this version of the mdc incorporates an upgraded light source, and updates the firmware and the user interface. this results in shorter acquisition times and improved image and spectrum quality control. the mdc also consists of a point probe that is used to take detailed light measurements (call spectroscopy) from smaller regions of the cervix. the goal of the study is to see whether the mdc can perform better than standard methods in detecting cancerous or pre-cancerous abnormalities of the cervix. study subjects will be swabbed for detection and typing of the human papilloma virus (hpv). after vinegar is applied on the cervix as per usual colposcopy practice, the mdc will then be used to take a sequence of images of the cervix. next 2-4 readings will be taken from the cervix using the point probe. this data will be used to train, test and validate an algorithm specific to the mdc. the ability of the algorithm to detect cervical intraepithelial neoplasia will be compared to standard clinical care (colposcopy). the mdc images and pathology results will be compared to the spectroscopy data from the mdc probe. the investigators will determine if spectroscopy has equal sensitivity to colposcopy for detecting high grade lesions.

Eligibility criteria:
inclusion criteria: * women who are at least 18 years old * are not pregnant (negative urine test) or breastfeeding * referred for colposcopy or leep treatment * can provide written informed consent exclusion criteria: * women who do not meet the inclusion criteria * women who have had a hysterectomy
natural history of lung nodules seen on ct scans from participants at high-risk of developing lung cancer

Conditions: Lung Cancer; Precancerous Condition

Summary: rationale: comparing lung ct scans from participants with lung nodules at high-risk for lung cancer may help doctors learn more about the disease and find better methods of treatment. purpose: this trial studies the natural history of lung nodules using ct scans from participants at high-risk for lung cancer.

objectives: primary * evaluation of lung nodules (target and non-target lesions) detected during annual low-dose (ld) computed tomography (ct) scans and measured for three years after study completion in subjects enrolled in a randomized, phase iib, placebo-controlled trial with inhaled budesonide (both person-specific and lesion-specific analyses will be performed). secondary * lung cancer detection rate in the two arms. * appearance of new nodules in the two arms. outline: low-dose ct scans are analyzed retrospectively for the natural progression of undetermined lung nodules. nodule dimension will be evaluated according to maximum diameter and volume, when feasible. volume measurements are performed using an automatic and semi-automatic computer-aided diagnosis (cad) system. lesion-specific and person-specific analysis are performed by measure of average change in size of the target lesions or number of lesions.

Eligibility criteria:
disease characteristics: * annual computed tomography (ct) scans obtained from participants with undetermined lung nodules detected by low-dose ct enrolled in both of the following trials: * a large-scale cosmos screening trial * three annual ct scans obtained as part of the cosmos trial after budesonide study treatment completion * the mda05-5-01, a subset of cosmos trial participants, a randomized phase ii trial of inhaled budesonide twice daily versus placebo * two ct scans performed as part of the budesonide protocol (mda05-5-01) * only ct scans from participants enrolled in both trials will be used patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: lung cancer precancerous condition lung nodules ct scan
a study to evaluate the effects of manidipine versus amlodipine and the combination of manidipine plus delapril versus amlodipine plus delapril on intraglomerular pressure in hypertensive patients

Conditions: Hypertension

Summary: eight-week multi-national, multicenter, randomized, double blind, active control, two arms, parallel groups study with a 4-week single drug treatment (manidipine or amlodipine) phase followed by a 4-week combination treatment (manidipine + delapril or amlodipine + delapril) phase.

the aim of the current study is to assess the effect of a 4-week single drug treatment with manidipine or amlodipine and a 4-week combination treatment with manidipine plus delapril or amlodipine plus delapril on intraglomerular pressure in subjects with hypertension.

Eligibility criteria:
inclusion criteria: * male or female patients aged 18 years or older * mild to moderate hypertension (systolic blood pressure \> 139 mmhg or diastolic blood pressure \> 89 mmhg) exclusion criteria: * secondary form of arterial hypertension * severe hypertension (systolic blood pressure \> 179 mmhg or diastolic blood pressure \> 109 mmhg) * pregnant or lactating women

Keywords: hypertension intraglomerular pressure